BEUDAMED
    FDA Enforcement Class II Terminated

    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.

    Recall: Z-0251-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0251-2016
    Event ID
    72376
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shimadzu Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    September 30, 2015
    Classification Date
    November 9, 2015
    Termination Date
    September 12, 2016
    Address
    20101 S Vermont Ave, N/A, Torrance, CA, 90502-1328, United States

    Description

    Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table.

    Reason

    The C-arm may interfere with the table top under certain circumstances.

    Code Info

    Serial Numbers: 0161H25201 0161H25702 0161H25801 0161H28201 0161H27301 0261H26201 0161H29501 0161H29901 0261H26101 0261H26002 0161H25401 0161H29302 0161H26201 0161H27102 0161H25701 0161H26402 0161H26701 0161H29001 0161H26302 0161H25602 0161H26702 0161H28501 0261H25401 0161H28001 0161H27402 0161H27201

    Distribution

    Worldwide Distribution. US (Texas, Wisconsin, Ohio, and Connecticut), Iran, India, Saudi Arabia, Serbia, Thailand, Germany, Croatia, Turkey, Lebanon, Korea, and China.

    Quantity

    26 units total (4 units in US)